Open Sesame: Congress Adds Sesame to the List of Major Food Allergens
Update: President Biden signed the FASTER Act into law on April 23, 2021. On April 14, 2021, Congress passed the Food Allergy … more
FFDCA
Stem Cell Therapy and the Practice of Medicine
Historically, FDA has stated in various contexts that it does not intend to regulate the practice of medicine. Indeed, the Federal Food, … more
21st Century Cures Act Provides (Some) Clarity on FDA’s Regulation of Software
On December 13, 2016, President Obama signed the 21st Century Cures Act (Public Law No. 114-255) (“the Act”) into law. This sweeping … more